As soon as Dianthus Therapeutics Inc. disclosed its early “go” decision on claseprubart in chronic inflammatory demyelinating polyneuropathy (CIDP), Wall Street set about comparing the phase III monoclonal antibody (mAb) to other prospects in the space, with particular focus on Sanofi SA’s riliprubart (SAR-455088).
Roivant Sciences Ltd. CEO Matt Cline said the firm’s unit Immunovant Inc. with FcRn blocker batoclimab has established “frankly a new bar” in myasthenia gravis (MG) as the New York-based firm reported top-line results from its phase III study and first data from period 1 of the phase IIb study with the same drug in chronic inflammatory demyelinating polyneuropathy. The data look promising, and Immunovant intends to use the findings to help advance second-generation FcRn prospect IMVT-1402 in both indications. Potentially registrational trials are planned. The U.S. FDA has granted IND clearance.
The U.S. FDA approval won in June by Argenx SE of subcutaneously given Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase) for adults with chronic inflammatory demyelinating polyneuropathy (CIDP) sparked interest in other prospects taking aim at the rare disease. Some – including Argenx – are going after generalized myasthenia gravis and multifocal motor neuropathy with their compounds.
Argenx SE gained U.S. FDA approval of subcutaneously given Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) for adult patients with chronic inflammatory demyelinating polyneuropathy (CIDP). The company’s stock (NASDAQ:ARGX) was up 11.7% to $440.59 at the close of trading June 24. About 24,000 people in the U.S. are being treated for CIDP, and patients are generally diagnosed between 40 and 60 years of age.
Zai Lab Ltd., of Shanghai and Cambridge, Mass., has been on a regulatory roll in China, gaining approval of Bristol Myers Squibb Co.’s Augtyro (repotrectinib) for lung cancer on May 12 and NMPA acceptance of subcutaneous Vyvgart‘s (efgartigimod alfa SC) supplemental BLA with priority review on May 14.
Zai Lab Ltd., of Shanghai and Cambridge, Mass., has been on a regulatory roll in China, gaining approval of Bristol Myers Squibb Co.’s Augtyro (repotrectinib) for lung cancer on May 12 and NMPA acceptance of subcutaneous Vyvgart‘s (efgartigimod alfa SC) supplemental BLA with priority review on May 14.
The picture keeps getting brighter for Argenx SE which, having targeted $750 million in a financing after positive phase II data, priced a global public offering of $1.1 billion, one of history’s larger rounds. Amsterdam-based Argenx capitalized on positive top-line data from the phase II Adhere study with Vyvgart Hytrulo (efgartigimod alfa plus hyaluronidase-qvfc) in chronic inflammatory demyelinating polyneuropathy.
Argenx SE’s top-line results from the phase II Adhere study with Vyvgart Hytrulo (efgartigimod alfa plus hyaluronidase-qvfc) in chronic inflammatory demyelinating polyneuropathy (CIDP) sparked buzz about other developers in the space with similar mechanisms of action to Vyvgart Hytrulo, such as Immunovant Inc.
